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    Clinical Trial Results:
    A Phase III, Randomized, Multicenter, Parallel-Group, Double-Blind, Double-Dummy Study in Adolescent and Adult Female Participants Comparing the Efficacy and Safety of Gepotidacin to Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis)

    Summary
    EudraCT number
    		 2018-001801-98
    Trial protocol
    		 GB   DE   BG   GR   HU   CZ   SK   RO  
    Global end of trial date
    30 Nov 2022

    Results information
    Results version number
    		 v2(current)
    This version publication date
    30 Jul 2023
    First version publication date
    14 Jun 2023
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction

    Trial information

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    Trial identification
    Sponsor protocol code
    204989
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04020341
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 GreatWest Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002443-PIP01-18
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Feb 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Nov 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the combined clinical and microbiological efficacy of gepotidacin compared to nitrofurantoin, at the Test-of-Cure (TOC) Visit, in female participants with acute cystitisin the Microbiological Intent-to-Treat Nitrofurantoin-Susceptible (micro-ITT NTF-S) Population
    Protection of trial subjects
    Not Applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Oct 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 335
    Country: Number of subjects enrolled
    Czechia: 42
    Country: Number of subjects enrolled
    Germany: 13
    Country: Number of subjects enrolled
    Greece: 19
    Country: Number of subjects enrolled
    Hungary: 34
    Country: Number of subjects enrolled
    India: 35
    Country: Number of subjects enrolled
    Mexico: 188
    Country: Number of subjects enrolled
    Romania: 116
    Country: Number of subjects enrolled
    Slovakia: 83
    Country: Number of subjects enrolled
    Spain: 23
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    United States: 635
    Worldwide total number of subjects
    1531
    EEA total number of subjects
    665
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    15
    Adults (18-64 years)
    1124
    From 65 to 84 years
    378
    85 years and over
    14

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 1680 participants were screened out of which1531 participants were randomly assigned to the study treatment were included in Intent-to-Treat (ITT) population.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Gepotidacin
    Arm description
    		 Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gepotidacin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants with uncomplicated urinary tract infection (acute cystitis) were administered with oral doses of 1500 milligrams (mg) (2*750 mg) gepotidacin tablet plus nitrofurantoin capsules matching placebo twice daily (BID) for 5 days.

    Arm title
    		 Nitrofurantoin
    Arm description
    		 Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Nitrofurantoin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants with uncomplicated urinary tract infection (acute cystitis) were administered with oral doses of 100 mg (25 mg nitrofurantoin macrocrystals and 75 mg nitrofurantoin) nitrofurantoin capsules plus gepotidacin tablet matching placebo BID for 5 days.

    Number of subjects in period 1
    		Gepotidacin Nitrofurantoin
    Started
    767
    764
    Safety Population
    766
    760
    Microbiological ITT Population
    401 [1]
    365 [2]
    Micro-ITT NTF-S Population
    336 [3]
    298 [4]
    Micro-ITT NTF-S (IA Set) Population
    320 [5]
    287 [6]
    Completed
    734
    736
    Not completed
    33
    28
         Consent withdrawn by subject
    16
    16
         Physician decision
    -
    2
         Adverse event, non-fatal
    8
    6
         Protocol Deviation
    -
    2
         Participant not able to swallow the tablet
    1
    -
         Lost to follow-up
    8
    2
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: intermediate milestone is a subset of started population. Hence number of subjects at this milestone are less than started.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: intermediate milestone is a subset of started population. Hence number of subjects at this milestone are less than started.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: intermediate milestone is a subset of started population. Hence number of subjects at this milestone are less than started.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: intermediate milestone is a subset of started population. Hence number of subjects at this milestone are less than started.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: intermediate milestone is a subset of started population. Hence number of subjects at this milestone are less than started.
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: intermediate milestone is a subset of started population. Hence number of subjects at this milestone are less than started.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Gepotidacin
    Reporting group description
    		 Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.

    Reporting group title
    Nitrofurantoin
    Reporting group description
    		 Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.

    Reporting group values
    		 Gepotidacin Nitrofurantoin Total
    Number of subjects
    		 767 764 1531
    Age Categorical
    Units: Participants
        Less than (<) 18 years
    		 6 9 15
        More than or equal to (>=) 18 years to 50 years
    		 372 369 741
        More than (>) 50 years
    		 389 386 775
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 49.6 ( 17.82 ) 50.4 ( 18.17 ) -
    Sex/Gender, Customized
    Units: Participants
        Female
    		 767 764 1531
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 278 270 548
        Not Hispanic or Latino
    		 489 494 983
        Unknown or Not Reported
    		 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 62 75 137
        Asian
    		 23 21 44
        Native Hawaiian or Other Pacific Islander
    		 3 1 4
        Black or African American
    		 40 40 80
        White
    		 627 621 1248
        More than one race
    		 12 6 18
        Unknown or Not Reported
    		 0 0 0
    Baseline Acute Cystitis Recurrence
    Recurrent infection was defined as a confirmed infection with at least 1 episode within the past 3 months, at least 2 episodes within the past 6 months, or at least 3 episodes within the past 12 months before study entry. Parameter type: Count of Participants
    Units: Subjects
        Recurrent Infection
    		 312 309 621
        Non-Recurrent Infection
    		 455 455 910
    Age, Customized
    Units: Subjects
        Less than (<) 18 years
    		 6 9 15
        More than or equal to (>=) 18 years to 50 years
    		 372 369 741
        More than (>) 50 years
    		 389 386 775

    End points

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    End points reporting groups
    Reporting group title
    Gepotidacin
    Reporting group description
    		 Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.

    Reporting group title
    Nitrofurantoin
    Reporting group description
    		 Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.

    Primary: Number of participants with therapeutic response (TR) (combined per participant clinical and microbiological response) at the Test-of-Cure (TOC) visit - Micro-ITT NTF-S ([Interim Analysis] IA Set)

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    End point title
    		 Number of participants with therapeutic response (TR) (combined per participant clinical and microbiological response) at the Test-of-Cure (TOC) visit - Micro-ITT NTF-S ([Interim Analysis] IA Set)
    End point description
    Therapeutic response (success/failure) is a measure of the overall efficacy response. A therapeutic success referred to participants who had been deemed both a "microbiological success"(reduction of all qualifying bacterial uropathogens [greater than or equal to {>=}10^5 colony-forming units per milliliter {CFU/mL}] recovered at Baseline to less than (<)10^3 CFU/mL as observed on quantitative urine culture without the participant receiving other systemic antimicrobials before the TOC Visit) and a "clinical success" (resolution of signs and symptoms of acute cystitis present at Baseline [and no new signs and symptoms] without the participant receiving other systemic antimicrobials before the TOC Visit). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
    End point type
    Primary
    End point timeframe
    TOC visit (Days 9 to 16)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    320
    287
    Units: Participants
        Therapeutic Success
    162
    135
        Therapeutic Failure
    158
    152
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Gepotidacin v Nitrofurantoin
    Number of subjects included in analysis
    607
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    P-value
    		 = 0.1445
    Method
    		 1-sided p-value for Test of Superiority
    Parameter type
    		 Adjusted difference of Percent
    Point estimate
    4.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.6
         upper limit
    		 12.1
    Notes
    [1] - The difference in success rate between treatment groups (gepotidacin – nitrofurantoin) was calculated using Miettinen-Nurminen Summary Score Method adjusted for age group and acute cystitis recurrence strata combinations. Criteria for superiority is if the one-sided p-value is less than the 0.019 p-value boundary.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Gepotidacin v Nitrofurantoin
    Number of subjects included in analysis
    607
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    Method
    		 Z Statistics for Non-inferiority=3.5554
    Parameter type
    		 Adjusted Difference in Percent
    Point estimate
    4.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.6
         upper limit
    		 12.1
    Notes
    [2] - The difference in success rate between treatment groups (gepotidacin – nitrofurantoin) was calculated using Miettinen-Nurminen Summary Score Method adjusted for age group and acute cystitis recurrence strata combinations. Criteria for non-inferiority is if the Z-statistic for non-inferiority is greater than the Z-statistic boundary (2.065).

    Primary: Number of participants with therapeutic response (TR) (combined per participant clinical and microbiological response) at the Test-of-Cure (TOC) visit – Micro-ITT NTF-S population

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    End point title
    		 Number of participants with therapeutic response (TR) (combined per participant clinical and microbiological response) at the Test-of-Cure (TOC) visit – Micro-ITT NTF-S population [3]
    End point description
    TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at Baseline [BL] to <10^3 colony forming units per milliliter [CFU/mL] without receiving other systemic antimicrobials [AB] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit [or AB for uUTI on day of TOC visit]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
    End point type
    Primary
    End point timeframe
    TOC visit (Days 9 to 16)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive; hence no statistical analysis to report.
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    336
    298
    Units: Participants
        Therapeutic Success
    174
    140
        Therapeutic Failure
    162
    158
    No statistical analyses for this end point

    Secondary: Number of participants with clinical response at the TOC visit - Micro-ITT NTF-S population

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    End point title
    		 Number of participants with clinical response at the TOC visit - Micro-ITT NTF-S population
    End point description
    Clinical response at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as resolution of symptoms of acute cystitis present at BL (and no new symptoms), without receiving any other AB before the TOC visit. Lack of resolution, including receipt of an AB for uUTI at the TOC visit, or a missing outcome assessment was defined as Clinical Failure at TOC.
    End point type
    Secondary
    End point timeframe
    TOC visit (Days 9 to 16)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    336
    298
    Units: Participants
        Clinical success
    224
    196
        Clinical failure
    112
    102
    No statistical analyses for this end point

    Secondary: Number of participants with microbiological response at the TOC visit – Micro-ITT NTF-S population

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    End point title
    		 Number of participants with microbiological response at the TOC visit – Micro-ITT NTF-S population
    End point description
    Participant-level microbiological response at TOC was categorized as microbiological success and microbiological failure. Microbiological success at TOC was defined as all baseline qualifying uropathogens (QUP)s had a microbiological outcome of eradication at TOC visit. Microbiological failure was defined as lack of microbiological success, including those participants with UTD outcomes.
    End point type
    Secondary
    End point timeframe
    TOC visit (Days 9 to 16)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    336
    298
    Units: Participants
        Microbiological success
    244
    199
        Microbiological failure
    92
    99
    No statistical analyses for this end point

    Secondary: Number of participants with clinical outcome at the TOC visit - Micro-ITT NTF-S population

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    End point title
    		 Number of participants with clinical outcome at the TOC visit - Micro-ITT NTF-S population
    End point description
    Clinical outcomes at TOC were categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution of signs and symptoms of acute cystitis present at baseline (BL) (and no symptoms) without receiving any other AB before the TOC visit. Clinical improvement at TOC was defined as improvement (but not complete resolution) in total symptom score (CSS) from BL, without receiving any other AB before the TOC visit. Clinical worsening at TOC was defined as worsening or no change in CSS from BL or received other AB for the current infection (uUTI) before or on the date of the TOC visit. Unable to determine outcome criteria were: BL score is missing (and thus improvement/worsening cannot be determined), TOC assessment is missing, or receipt of other AB not for the current infection before the TOC visit (unless clinical worsening outcome criteria were met).
    End point type
    Secondary
    End point timeframe
    TOC visit (Days 9 to 16)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    336
    298
    Units: Participants
        Clinical resolution
    224
    196
        Clinical improvment
    82
    75
        Clinical worsening
    9
    16
        Unable to determine
    21
    11
    No statistical analyses for this end point

    Secondary: Number of participants with microbiological outcome (MO) at the TOC visit – Micro-ITT NTF-S population

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    End point title
    		 Number of participants with microbiological outcome (MO) at the TOC visit – Micro-ITT NTF-S population
    End point description
    Participant-level MOs at TOC were categorized as microbiological eradication (ME), microbiological persistence (MP), microbiological recurrence (MR) and unable to determine (UTD). ME at TOC was defined as all baseline qualifying uropathogens (QUP) have an outcome of eradication at TOC (i.e., <10^3 CFU/mL without the participant receiving other systemic antimicrobials before the TOC Visit). MP at TOC was defined as at least 1 QUP has an outcome of persistence (≥10^3 CFU/mL) at TOC. MR at TOC was defined as at least 1 QUP had an outcome of recurrence and none have an outcome of persistence at TOC. UTD at TOC was defined as all QUP outcomes are UTD at TOC.
    End point type
    Secondary
    End point timeframe
    TOC Visit (Days 9 to 16)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    336
    298
    Units: Participants
        Microbiological Eradication (ME)
    244
    199
        Microbiological Persistence (MP)
    15
    21
        Microbiological Recurrence (MR)
    36
    52
        Unable to determine (UTD)
    41
    26
    No statistical analyses for this end point

    Secondary: Number of participants with therapeutic response (TR) (combined per participant clinical and microbiological response) at the follow up visit- Micro-ITT NTF-S population

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    End point title
    		 Number of participants with therapeutic response (TR) (combined per participant clinical and microbiological response) at the follow up visit- Micro-ITT NTF-S population
    End point description
    TR at FU was categorized as therapeutic success and therapeutic failure. A therapeutic success at FU referred to participants who have been deemed both a microbiological success (reduction of all QUPs recovered at BL to <10^3 CFU/mL, following microbiological eradication at the TOC visit, without receiving other AB before the FU visit) and a clinical success (resolution of signs and symptoms of acute cystitis demonstrated at the TOC visit persist at the FU visit and no new signs and symptoms, without receiving other AB before the FU visit [or AB for uUTI on day of FU visit]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
    End point type
    Secondary
    End point timeframe
    FU visit (Days 21 to 31)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    336
    298
    Units: Participants
        Therapeutic Success
    117
    94
        Therapeutic Failure
    219
    204
    No statistical analyses for this end point

    Secondary: Number of participants with clinical outcome at the follow up (FU) visit - Micro-ITT NTF-S population

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    End point title
    		 Number of participants with clinical outcome at the follow up (FU) visit - Micro-ITT NTF-S population
    End point description
    Clinical outcomes at FU were categorized as SCR, DCR, CI, CW, CR and (UTD. SCR at FU was resolution of symptoms of acute cystitis demonstrated at the TOC persist at the FU (and no symptoms), without receiving other AB before the FU. DCR at FU was resolution of symptoms of acute cystitis present at BL after clinical failure at TOC without receiving AB before FU. CI at FU was improvement in CSS from BL, but not complete resolution without receiving AB before FU. CW at FU was worsening or no change in CSS at FU compared to BL after clinical failure at TOC or receiving other AB for the current infection (uUTI) before or on the date of the FU. CR at FU was symptoms of acute cystitis reoccur at FU after clinical success at TOC. Unable to determine outcome criteria at FU were BL score missing, FU assessment missing or received other AB not for the current infection (uUTI) prior to the assessment (unless CS or CR outcome criteria were met).
    End point type
    Secondary
    End point timeframe
    FU visit (Days 21 to 31)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    336
    298
    Units: Participants
        Sustained clinical resolution (SCR)
    184
    162
        Delayed clinical resolution (DCR)
    61
    44
        Clinical improvement (CI)
    28
    27
        Clinical worsening (CW)
    12
    23
        Clinical recurrence (CR)
    11
    11
        Unable to determine (UTD)
    40
    31
    No statistical analyses for this end point

    Secondary: Number of participants with microbiological outcome (MO) at the follow up (FU) visit – Micro-ITT NTF-S population

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    End point title
    		 Number of participants with microbiological outcome (MO) at the follow up (FU) visit – Micro-ITT NTF-S population
    End point description
    Participant-level MOs at FU were categorized as sustained microbiological eradication (SME), microbiological recurrence (MR), microbiological persistence (MP), delayed microbiological eradication (DME) and unable to determine (UTD). SME at FU was defined as all baseline QUPs had an outcome of sustained eradication at FU (i.e., <10^3 CFU/mL without the participant receiving other systemic antimicrobials before the FU Visit). MR at FU was defined as at least one QUP had an outcome of recurrence (≥10^3 CFU/mL) and none had an outcome of persistence at FU. MP at FU was defined as at least one QUP had an outcome of persistence at FU. DME at FU was defined as at least one QUP had an outcome of delayed eradication and none had an outcome of persistence or recurrence at FU. UTD at FU was defined as all QUP outcomes were unable to determine at FU.
    End point type
    Secondary
    End point timeframe
    FU visit (Days 21 to 31)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    336
    298
    Units: Participants
        Sustained microbiological eradication (SME)
    174
    136
        Microbiological persistence (MP)
    32
    38
        Microbiological recurrence (MR)
    36
    35
        Delayed microbiological eradication (DME)
    34
    31
        Unable to determine (UTD)
    60
    58
    No statistical analyses for this end point

    Secondary: Number of participants with clinical response at the follow up (FU) visit - Micro-ITT NTF-S population

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    End point title
    		 Number of participants with clinical response at the follow up (FU) visit - Micro-ITT NTF-S population
    End point description
    Clinical response at FU was categorized as clinical success and clinical failure. Clinical success at FU was defined as resolution of symptoms of acute cystitis demonstrated at TOC persist at the FU visit (and no new symptoms), without receiving other AB before the FU visit. Lack of sustained clinical resolution or a missing outcome assessment was defined as clinical failure.
    End point type
    Secondary
    End point timeframe
    FU visit (Days 21 to 31)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    336
    298
    Units: Participants
        Clinical success
    184
    162
        Clinical failure
    152
    136
    No statistical analyses for this end point

    Secondary: Number of participants with clinical outcome at the TOC visit - Intent-to-Treat (ITT) population

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    End point title
    		 Number of participants with clinical outcome at the TOC visit - Intent-to-Treat (ITT) population
    End point description
    Clinical outcomes at TOC were categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution symptoms of acute cystitis present at baseline (BL) (and no symptoms) without receiving any other AB before the TOC visit. Clinical improvement at TOC was defined as improvement (but not complete resolution) in CSS from BL, without receiving any other AB before the TOC visit. Clinical worsening at TOC was defined as worsening or no change in CSS from BL or received other AB for the current infection (uUTI) before or on the date of the TOC visit. Unable to determine outcome criteria were: BL score is missing (and thus improvement/worsening cannot be determined), TOC assessment is missing, or receipt of other AB not for the current infection before the TOC visit (unless clinical worsening outcome criteria were met).
    End point type
    Secondary
    End point timeframe
    TOC visit (Days 9 to 16)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    767
    764
    Units: Participants
        Clinical resolution
    497
    484
        Clinical improvement
    194
    206
        Clinical worsening
    26
    37
        Unable to determine
    50
    37
    No statistical analyses for this end point

    Secondary: Number of participants with microbiological response at the follow up (FU) visit – Micro-ITT NTF-S population

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    End point title
    		 Number of participants with microbiological response at the follow up (FU) visit – Micro-ITT NTF-S population
    End point description
    Participant- level microbiological response at FU was categorized as microbiological success and microbiological failure. Microbiological success at FU was defined as all baseline QUPs had a microbiological outcome of sustained eradication at FU visit. Microbiological failure at FU was defined as not meeting criteria of microbiological success including those participants with UTD outcome.
    End point type
    Secondary
    End point timeframe
    FU visit (Days 21 to 31)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    336
    298
    Units: Participants
        Microbiological Success
    174
    136
        Microbiological Failure
    162
    162
    No statistical analyses for this end point

    Secondary: Number of participants with clinical outcome at the follow up (FU) visit - Intent-to-Treat (ITT) population

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    End point title
    		 Number of participants with clinical outcome at the follow up (FU) visit - Intent-to-Treat (ITT) population
    End point description
    Clinical outcomes at FU were categorized as SCR, DCR, CI, CW, CR and (UTD. SCR at FU was resolution of symptoms of acute cystitis demonstrated at the TOC persist at the FU (and no symptoms), without receiving other AB before the FU. DCR at FU was resolution of symptoms of acute cystitis present at BL after clinical failure at TOC without receiving AB before FU. CI at FU was improvement in CSS from BL, but not complete resolution without receiving AB before FU. CW at FU was worsening or no change in CSS at FU compared to BL after clinical failure at TOC or receiving other AB for the current infection (uUTI) before or on the date of the FU. CR at FU was symptoms of acute cystitis reoccur at FU after clinical success at TOC. Unable to determine outcome criteria at FU were BL score missing, FU assessment missing or received other AB not for the current infection (uUTI) prior to the assessment (unless CS or CR outcome criteria were met).
    End point type
    Secondary
    End point timeframe
    FU visit (Days 21 to 31)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    767
    764
    Units: Participants
        Sustained clinical resolution (SCR)
    421
    404
        Delayed clinical resolution (DCR)
    130
    127
        Clinical improvement (CI)
    75
    71
        Clinical worsening (CW)
    29
    48
        Clinical recurrence (CR)
    25
    30
        Unable to determine (UTD)
    87
    84
    No statistical analyses for this end point

    Secondary: Number of participants with clinical response at the TOC visit - Intent-to-Treat (ITT) population

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    End point title
    		 Number of participants with clinical response at the TOC visit - Intent-to-Treat (ITT) population
    End point description
    Clinical response at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as resolution of signs and symptoms of acute cystitis present at BL (and no new symptoms), without receiving any other AB before the TOC visit. Lack of resolution, including receipt of an AB for uUTI at the TOC visit, or a missing outcome assessment was defined as Clinical Failure.
    End point type
    Secondary
    End point timeframe
    TOC visit (Days 9 to 16)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    767
    764
    Units: Participants
        Clinical success
    497
    484
        Clinical failure
    270
    280
    No statistical analyses for this end point

    Secondary: Number of participants with clinical response at the follow up (FU) visit - Intent-to-Treat (ITT) population

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    End point title
    		 Number of participants with clinical response at the follow up (FU) visit - Intent-to-Treat (ITT) population
    End point description
    Clinical response at FU was categorized as clinical success and clinical failure. Clinical success at FU was defined as resolution of symptoms of acute cystitis demonstrated at TOC persist at the FU visit (and no new symptoms), without receiving other AB before the FU visit. Lack of sustained clinical resolution or a missing outcome assessment was defined as clinical failure.
    End point type
    Secondary
    End point timeframe
    FU visit (Days 21 to 31)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    767
    764
    Units: Participants
        Clinical success
    421
    404
        Clinical failure
    346
    360
    No statistical analyses for this end point

    Secondary: Plasma concentration of gepotidacin

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    End point title
    		 Plasma concentration of gepotidacin [4]
    End point description
    Blood samples were collected for plasma concentration of gepotidacin. Pharmacokinetic (PK) Population included all randomized participants who received at least 1 dose of study treatment and had at least 1 non missing plasma or urine PK concentration. Only those participants with data available at specified time points have been analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) 0-2 hour (h) and >2h post-dose; On-therapy (Day 2), morning (am) pre-dose, 0-6h, 6-8h, 8-10h, 10-12h post-dose, 0-2h, >2h evening (pm) post-dose; On-therapy (Day 3 to 5), 0-6h, 6-8h, 8-10h, 10-12h post-dose
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only analyzed for gepotidacin arm.
    End point values
    		 Gepotidacin
    Number of subjects analysed
    495
    Units: Microgram/millilitre (ug/mL)
    arithmetic mean (standard deviation)
        Baseline Day 1, 0-2hour (h) post-dose
    8.52 ( 84.21 )
        Baseline Day 1, >2h post-dose
    2.96 ( 1.865 )
        On-Therapy Day 2, am, pre-dose
    3.48 ( 21.58 )
        On-Therapy Day 2, 0-6h, am, post-dose
    4.20 ( 4.210 )
        On-Therapy Day 2, 6-8h, am, post-dose
    1.22 ( 0.4729 )
        On-Therapy Day 2, 8-10h, am, post-dose
    1.10 ( 1.103 )
        On-Therapy Day 2, 10-12h, am, post-dose
    1.26 ( 1.358 )
        On-Therapy Day 2, 0-2h, pm post-dose
    2.56 ( 2.717 )
        On-Therapy Day 2, >2h, pm, post-dose
    2.61 ( 2.579 )
        On-Therapy Day 3 to 5, 0-6h post-dose
    4.10 ( 3.955 )
        On-Therapy Day 3 to 5, 6-8h post-dose
    2.54 ( 3.006 )
        On-Therapy Day 3 to 5, 8-10h post-dose
    1.08 ( 0.9247 )
        On-Therapy Day 3 to 5, 10-12h post-dose
    1.17 ( 1.688 )
    No statistical analyses for this end point

    Secondary: Urine concentration of gepotidacin

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    End point title
    		 Urine concentration of gepotidacin [5]
    End point description
    Urine samples were collected from participants. Pharmacokinetic (PK) Population included all randomized participants who received at least 1 dose of study treatment and had at least 1 non missing plasma or urine PK concentration. Only those participants with data available at specified time points have been analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) 0-2 hour (h) and >2h post-dose; On-therapy (Day 2), morning (am) pre-dose, 0-6h, 6-8h, 8-10h, 10-12h post-dose, 0-2h, >2h evening (pm) post-dose; On-therapy (Day 3 to 5), 0-6h, 6-8h, 8-10h, 10-12h post-dose
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only analyzed for gepotidacin arm.
    End point values
    		 Gepotidacin
    Number of subjects analysed
    490
    Units: ug/mL
    arithmetic mean (standard deviation)
        Baseline Day 1, 0-2hour (h) post-dose
    317 ( 680.3 )
        Baseline Day 1, >2h post-dose
    857 ( 1539 )
        On-Therapy Day 2, am, pre-dose
    391 ( 402.5 )
        On-Therapy Day 2, 0-6h, am, post-dose
    781 ( 1449 )
        On-Therapy Day 2, 6-8h, am, post-dose
    363 ( 443.7 )
        On-Therapy Day 2, 8-10h, am, post-dose
    326 ( 274.4 )
        On-Therapy Day 2, 10-12h, am, post-dose
    287 ( 423.2 )
        On-Therapy Day 2, 0-2h, pm post-dose
    156 ( 216.1 )
        On-Therapy Day 2, >2h, pm, post-dose
    624 ( 0 )
        On-Therapy Day 3 to 5, 0-6h post-dose
    651 ( 1313 )
        On-Therapy Day 3 to 5, 6-8h post-dose
    259 ( 164.9 )
        On-Therapy Day 3 to 5, 8-10h post-dose
    522 ( 663.1 )
        On-Therapy Day 3 to 5, 10-12h post-dose
    370 ( 498.8 )
    No statistical analyses for this end point

    Secondary: Number of participants with treatment-emergent adverse events (TEAEs)

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    End point title
    		 Number of participants with treatment-emergent adverse events (TEAEs)
    End point description
    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. Safety population included all randomized participants who receive at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    From the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    766
    760
    Units: Participants
    266
    165
    No statistical analyses for this end point

    Secondary: Number of participants with serious adverse events (SAEs)

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    End point title
    		 Number of participants with serious adverse events (SAEs)
    End point description
    An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety population included all randomized participants who receive at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    From the time of first dose (Day 1) through the final follow-up visit (Day 21-31)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    766
    760
    Units: Participants
    2
    3
    No statistical analyses for this end point

    Secondary: Change from baseline in hematology parameters - neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count and platelet count at On Therapy and Test of Cure Visit

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    End point title
    		 Change from baseline in hematology parameters - neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count and platelet count at On Therapy and Test of Cure Visit
    End point description
    Blood samples were collected for the analysis of hematology parameters: neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count and platelet count. Baseline is defined as the latest pre-dose assessment with a non-missing value. Safety population included all randomized participants who receive at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    725
    704
    Units: Giga cells per Liter (10^9 cells/L)
    arithmetic mean (standard deviation)
        Basophils, Baseline
    0.053 ( 0.217 )
    0.055 ( 0.0256 )
        Basophils, On-Therapy
    -0.001 ( 0.187 )
    0.000 ( 0.0204 )
        Basophils, Test of Cure
    0.002 ( 0.0204 )
    0.001 ( 0.0244 )
        Eosinophils, Baseline
    0.152 ( 0.1137 )
    0.154 ( 0.1338 )
        Eosinophils, On-Therapy
    0.013 ( 0.0680 )
    0.017 ( 0.0691 )
        Eosinophils, Test of Cure
    0.024 ( 0.0770 )
    0.022 ( 0.0865 )
        Lymphocytes, Baseline
    2.074 ( 0.6603 )
    2.133 ( 2.0797 )
        Lymphocytes, On-Therapy
    0.009 ( 0.4233 )
    -0.026 ( 0.5333 )
        Lymphocytes, Test of Cure
    -0.003 ( 0.5106 )
    0.067 ( 0.6268 )
        Monocytes, Baseline
    0.528 ( 0.1808 )
    0.529 ( 0.1906 )
        Monocytes, On-Therapy
    -0.022 ( 0.1445 )
    -0.018 ( 0.1400 )
        Monocytes, Test of Cure
    -0.022 ( 0.1528 )
    -0.010 ( 0.1678 )
        Neutrophils, Baseline
    4.715 ( 1.9781 )
    4.640 ( 1.8018 )
        Neutrophils, On-Therapy
    -0.540 ( 1.5771 )
    -0.519 ( 1.4975 )
        Neutrophils, Test of Cure
    -0.703 ( 1.7653 )
    -0.470 ( 1.7541 )
        Platelets, Baseline
    278.0 ( 70.32 )
    279.0 ( 73.76 )
        Platelets, On-Therapy
    2.4 ( 24.46 )
    2.6 ( 29.94 )
        Platelets, Test of Cure
    3.0 ( 39.74 )
    8.6 ( 47.92 )
    No statistical analyses for this end point

    Secondary: Change from baseline in hematology parameter-hemoglobin level at On Therapy and Test of Cure Visit

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    End point title
    		 Change from baseline in hematology parameter-hemoglobin level at On Therapy and Test of Cure Visit
    End point description
    Blood samples were collected for the analysis of hemoglobin level. Baseline is defined as the latest pre-dose assessment with a non-missing value. Safety population included all randomized participants who receive at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    726
    704
    Units: Gram per Liter (g/L)
    arithmetic mean (standard deviation)
        Hemoglobin, Baseline
    132.2 ( 13.13 )
    131.7 ( 14.33 )
        Hemoglobin, On-Therapy
    -0.1 ( 5.27 )
    -0.4 ( 6.39 )
        Hemoglobin, Test of Cure
    -0.9 ( 6.63 )
    -1.6 ( 7.27 )
    No statistical analyses for this end point

    Secondary: Change from baseline in hematology parameter- hematocrit level at On Therapy and Test of Cure Visit

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    End point title
    		 Change from baseline in hematology parameter- hematocrit level at On Therapy and Test of Cure Visit
    End point description
    Blood samples were collected for the analysis of hematocrit level. Baseline is defined as the latest pre-dose assessment with a non-missing value. Safety population included all randomized participants who receive at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    726
    704
    Units: Percentage of hematocrit
    arithmetic mean (standard deviation)
        Hematocrit, Baseline
    0.4302 ( 0.04292 )
    0.4282 ( 0.4584 )
        Hematocrit, On-Therapy
    0.0003 ( 0.02238 )
    -0.0007 ( 0.02431 )
        Hematocrit, Test of Cure
    -0.0023 ( 0.02689 )
    -0.0055 ( 0.02757 )
    No statistical analyses for this end point

    Secondary: Change from baseline in hematology parameter- erythrocytes count at On Therapy and Test of Cure Visit

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    End point title
    		 Change from baseline in hematology parameter- erythrocytes count at On Therapy and Test of Cure Visit
    End point description
    Blood samples were collected for the analysis of erythrocytes count. Baseline is defined as the latest pre-dose assessment with a non-missing value. Safety population included all randomized participants who receive at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    726
    704
    Units: Tera cells per Liter (10^12 cells/L)
    arithmetic mean (standard deviation)
        Erythrocytes, Baseline
    4.538 ( 0.4315 )
    4.515 ( 0.4324 )
        Erythrocytes, On-Therapy
    -0.005 ( 0.1900 )
    -0.011 ( 0.2247 )
        Erythrocytes, Test of Cure
    -0.033 ( 0.2377 )
    -0.048 ( 0.2528 )
    No statistical analyses for this end point

    Secondary: Change from baseline in hematology parameter - mean corpuscular hemoglobin (MCH) at On Therapy and Test of Cure Visit

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    End point title
    		 Change from baseline in hematology parameter - mean corpuscular hemoglobin (MCH) at On Therapy and Test of Cure Visit
    End point description
    Blood samples were collected for the analysis of MCH. Baseline is defined as the latest pre-dose assessment with a non-missing value. Safety population included all randomized participants who receive at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    726
    704
    Units: Picogram (pg)
    arithmetic mean (standard deviation)
        MCH, Baseline
    29.20 ( 2.392 )
    29.24 ( 2.499 )
        MCH, On-Therapy
    0.02 ( 0.500 )
    -0.03 ( 0.536 )
        MCH, Test of Cure
    0.02 ( 0.596 )
    -0.05 ( 0.644 )
    No statistical analyses for this end point

    Secondary: Change from baseline in hematology parameter - mean corpuscular volume (MCV) at On Therapy and Test of Cure Visit

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    End point title
    		 Change from baseline in hematology parameter - mean corpuscular volume (MCV) at On Therapy and Test of Cure Visit
    End point description
    Blood samples were collected for the analysis of MCV. Baseline is defined as the latest pre-dose assessment with a non-missing value. Safety population included all randomized participants who receive at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    726
    704
    Units: Femtoliter (fL)
    arithmetic mean (standard deviation)
        MCV, Baseline
    95.02 ( 7.057 )
    95.03 ( 7.438 )
        MCV, On-Therapy
    0.17 ( 3.269 )
    0.07 ( 3.248 )
        MCV, Test of Cure
    0.17 ( 3.511 )
    -0.019 ( 3.689 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in clinical chemistry parameters - Serum urea nitrogen, glucose, calcium, chloride, sodium, magnesium, phosphate, and potassium levels at On Therapy and Test of Cure Visit

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    End point title
    		 Change from Baseline in clinical chemistry parameters - Serum urea nitrogen, glucose, calcium, chloride, sodium, magnesium, phosphate, and potassium levels at On Therapy and Test of Cure Visit
    End point description
    Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value. Safety population included all randomized participants who receive at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    751
    741
    Units: millimoles per liter (mmol/L)
    arithmetic mean (standard deviation)
        Serum Calcium, Baseline
    2.357 ( 0.1118 )
    2.374 ( 0.1154 )
        Serum Calcium, On-Therapy
    -0.009 ( 0.0914 )
    -0.012 ( 0.992 )
        Serum Calcium, Test of Cure
    -0.016 ( 0.0981 )
    -0.016 ( 0.1017 )
        Serum Chloride, Baseline
    101.6 ( 3.23 )
    101.3 ( 3.08 )
        Serum Chloride, On-Therapy
    0.2 ( 2.59 )
    0.0 ( 2.49 )
        Serum Chloride, Test of Cure
    0.4 ( 2.88 )
    0.2 ( 2.67 )
        Serum Glucose, Baseline
    5.778 ( 2.3665 )
    5.689 ( 1.9348 )
        Serum Glucose, On-Therapy
    0.199 ( 1.4728 )
    0.397 ( 1.5986 )
        Serum Glucose, Test of Cure
    0.156 ( 1.5893 )
    0.290 ( 1.5996 )
        Serum Magnesium, Baseline
    0.836 ( 0.0760 )
    0.831 ( 0.0781 )
        Serum Magnesium, On-Therapy
    -0.006 ( 0.0634 )
    -0.015 ( 0.0604 )
        Serum Magnesium, Test of Cure
    -0.008 ( 0.0626 )
    -0.014 ( 0.0616 )
        Serum Phosphate, Baseline
    1.138 ( 0.1641 )
    1.133 ( 0.1750 )
        Serum Phosphate, On-Therapy
    0.005 ( 0.1642 )
    -0.012 ( 0.1826 )
        Serum Phosphate, Test of Cure
    0.009 ( 0.1857 )
    0.008 ( 0.1908 )
        Serum Potassium, Baseline
    4.32 ( 0.441 )
    4.33 ( 0.447 )
        Serum Potassium, On-Therapy
    0.00 ( 0.443 )
    -0.01 ( 0.495 )
        Serum Potassium, Test of Cure
    0.00 ( 0.488 )
    0.01 ( 0.495 )
        Serum Sodium, Baseline
    139.5 ( 2.69 )
    139.2 ( 2.64 )
        Serum Sodium, On-Therapy
    -0.1 ( 2.41 )
    -0.2 ( 2.54 )
        Serum Sodium, Test of Cure
    0.0 ( 2.68 )
    -0.1 ( 2.64 )
        Serum Urea Nitrogen, Baseline
    4.855 ( 1.8877 )
    4.912 ( 2.1175 )
        Serum Urea Nitrogen, On-Therapy
    -0.039 ( 1.1285 )
    -0.045 ( 1.1848 )
        Serum Urea Nitrogen, Test of Cure
    0.031 ( 1.3613 )
    0.054 ( 1.5544 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in clinical chemistry parameters - Total bilirubin, direct bilirubin and creatinine levels at On Therapy and Test of Cure Visit

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    End point title
    		 Change from Baseline in clinical chemistry parameters - Total bilirubin, direct bilirubin and creatinine levels at On Therapy and Test of Cure Visit
    End point description
    Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value. Safety population included all randomized participants who receive at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline, On-Therapy (Days 2 to 4), and Test of cure (Days 10 to 13)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    750
    740
    Units: micromoles per Liter (umol/L)
    arithmetic mean (standard deviation)
        Serum direct bilirubin, Baseline
    4.71 ( 1.534 )
    4.78 ( 1.462 )
        Serum direct bilirubin, On-Therapy
    -0.26 ( 1.443 )
    -0.16 ( 1.276 )
        Serum direct bilirubin, Test of cure
    -0.24 ( 1.577 )
    -0.08 ( 1.534 )
        Serum Creatinine, Baseline
    59.5 ( 20.67 )
    59.3 ( 20.17 )
        Serum Creatinine, On-Therapy
    2.8 ( 13.51 )
    2.3 ( 23.79 )
        Serum Creatinine, Test of Cure
    0.9 ( 16.98 )
    2.2 ( 29.46 )
        Serum total bilirubin, Baseline
    6.72 ( 3.914 )
    6.77 ( 3.909 )
        Serum total bilirubin, On-Therapy
    -0.10 ( 2.718 )
    -0.15 ( 2.655 )
        Serum total bilirubin, Test of Cure
    -0.15 ( 2.904 )
    -0.16 ( 3.107 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in clinical chemistry parameters - albumin and total protein levels at On Therapy and Test of Cure Visit

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    End point title
    		 Change from Baseline in clinical chemistry parameters - albumin and total protein levels at On Therapy and Test of Cure Visit
    End point description
    Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value. Safety population included all randomized participants who receive at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline, On-Therapy (Days 2 to 4), and Test of cure (Days 10 to 13)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    752
    760
    Units: gram per Liter (g/L)
    arithmetic mean (standard deviation)
        Serum Albumin, Baseline
    45.2 ( 3.07 )
    45.4 ( 2.91 )
        Serum Albumin, On-Therapy
    0.0 ( 2.21 )
    -0.3 ( 2.06 )
        Serum Albumin, Test of Cure
    -0.5 ( 2.42 )
    -0.5 ( 2.50 )
        Serum Protein, Baseline
    71.6 ( 4.73 )
    71.8 ( 4.72 )
        Serum Protein, On-Therapy
    0.0 ( 3.70 )
    -0.4 ( 3.46 )
        Serum Protein, Test of Cure
    -0.9 ( 4.02 )
    -1.0 ( 3.76 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in clinical chemistry parameters - Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) levels at On Therapy and Test of Cure Visit

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    End point title
    		 Change from Baseline in clinical chemistry parameters - Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) levels at On Therapy and Test of Cure Visit
    End point description
    Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value. Safety population included all randomized participants who receive at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline, On-Therapy (Days 2 to 4), and Test of cure (Days 10 to 13)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    749
    739
    Units: Units per Liter (U/L)
    arithmetic mean (standard deviation)
        Serum ALP, Baseline
    79.0 ( 27.98 )
    78.4 ( 30.89 )
        Serum ALP, On-Therapy
    -0.5 ( 6.91 )
    0.1 ( 7.24 )
        Serum ALP, Test of Cure
    -1.5 ( 9.43 )
    0.0 ( 12.65 )
        Serum AST, Baseline
    20.1 ( 9.40 )
    21.5 ( 16.55 )
        Serum AST, On-Therapy
    0.5 ( 5.97 )
    0.1 ( 5.33 )
        Serum AST, Test of Cure
    1.1 ( 7.21 )
    1.6 ( 38.77 )
        Serum ALT, Baseline
    18.9 ( 13.55 )
    20.0 ( 17.84 )
        Serum ALT, On-Therapy
    0.8 ( 5.17 )
    0.2 ( 5.43 )
        Serum ALT, Test of Cure
    1.0 ( 8.93 )
    1.2 ( 23.91 )
    No statistical analyses for this end point

    Secondary: Number of participants with urinalysis dipstick results at Baseline, On Therapy and Test of Cure visit

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    End point title
    		 Number of participants with urinalysis dipstick results at Baseline, On Therapy and Test of Cure visit
    End point description
    Urine samples were collected for urinalysis: Urine Glucose (GLU), Urine Protein (PRO), Urine Occult Blood (BLO), Urine Ketones (KET), Urine Nitrite (NIT) and Urine Leukocyte Esterase (LEU). Baseline is defined as the latest pre-dose assessment with a non-missing value. The dipstick test gives results in a semi-quantitative manner, and results can be read as Negative, Trace, Small, Moderate, Large, Positive, 50 milligram per deciliter (mg/dL), 150 mg/dL, >=500 mg/dL, 30 mg/dL, 100 mg/dL, 200 mg/dL, 5 mg/dL, 20 mg/dL, >=80 mg/dL indicating concentrations in the urine sample. In the category (GLU, Baseline, Negative), GLU indicates parameter, Baseline is the visit and Negative indicates the concentration in the urine sample.
    End point type
    Secondary
    End point timeframe
    Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    756
    752
    Units: Participants
        GLU, Baseline, Negative
    703
    717
        GLU, Baseline, 50 mg/dL
    15
    5
        GLU, Baseline, 150 mg/dL
    4
    3
        GLU, Baseline, >= 500 mg/dL
    21
    15
        GLU, On-Therapy, Negative
    681
    680
        GLU, On-Therapy, 50 mg/dL
    11
    6
        GLU, On-Therapy, 150 mg/dL
    7
    4
        GLU, On-Therapy, >= 500 mg/dL
    22
    21
        GLU, Test of Cure, Negative
    672
    672
        GLU, Test of Cure, 50 mg/dL
    6
    4
        GLU, Test of Cure, 150 mg/dL
    2
    4
        GLU, Test of Cure, >= 500 mg/dL
    21
    20
        PRO, Baseline, Negative
    501
    501
        PRO, Baseline, 30 mg/dL
    179
    160
        PRO, Baseline, 100 mg/dL
    60
    72
        PRO, Baseline, >=500 mg/dL
    3
    6
        PRO, On-Therapy, Negative
    546
    587
        PRO, On-Therapy, 30 mg/dL
    133
    102
        PRO, On-Therapy, 100 mg/dL
    40
    20
        PRO, On-Therapy, >=500 mg/dL
    2
    2
        PRO, Test of Cure, Negative
    602
    591
        PRO, Test of Cure, 30 mg/dL
    77
    89
        PRO, Test of Cure, 100 mg/dL
    21
    15
        PRO, Test of Cure, >=500 mg/dL
    1
    5
        BLO, Baseline, Negative
    310
    297
        BLO, Baseline, Positive
    2
    0
        BLO, Baseline, Small
    248
    266
        BLO, Baseline, Moderate
    118
    107
        BLO, Baseline, Large
    72
    75
        BLO, On-Therapy, Negative
    531
    475
        BLO, On-Therapy, Small
    123
    167
        BLO, On-Therapy, Moderate
    38
    40
        BLO, On-Therapy, Large
    29
    29
        BLO, Test of Cure, Negative
    503
    510
        BLO, Test of Cure, Small
    124
    114
        BLO, Test of Cure, Moderate
    46
    50
        BLO, Test of Cure, Large
    28
    26
        KET, Baseline, Negative
    724
    726
        KET, Baseline, 5 mg/dL
    14
    8
        KET, Baseline, 20 mg/dL
    4
    5
        KET, Baseline, >=80 mg/dL
    1
    1
        KET, On-Therapy, Negative
    704
    688
        KET, On-Therapy, 5 mg/dL
    10
    20
        KET, On-Therapy, 20 mg/dL
    6
    2
        KET, On-Therapy, >=80 mg/dL
    1
    1
        KET, Test of Cure, Negative
    683
    688
        KET, Test of Cure, 5 mg/dL
    13
    11
        KET, Test of Cure, >=80 mg/dL
    5
    1
        NIT, Baseline, Negative
    466
    458
        NIT, Baseline, Positive
    286
    291
        NIT, On-Therapy, Negative
    655
    647
        NIT, On-Therapy, Positive
    66
    64
        NIT, Test of Cure, Negative
    662
    639
        NIT, Test of Cure, Positive
    39
    61
        LEU, Baseline, Negative
    186
    169
        LEU, Baseline, Trace
    80
    77
        LEU, Baseline, Small
    89
    74
        LEU, Baseline, Moderate
    109
    116
        LEU, Baseline, Large
    292
    314
        LEU, Baseline, Positive
    0
    2
        LEU, On-Therapy, Negative
    429
    387
        LEU, On-Therapy, Trace
    82
    86
        LEU, On-Therapy, Small
    48
    69
        LEU, On-Therapy, Moderate
    57
    63
        LEU, On-Therapy, Large
    105
    106
        LEU, Test of Cure, Negative
    506
    442
        LEU, Test of Cure, Trace
    60
    73
        LEU, Test of Cure, Small
    38
    54
        LEU, Test of Cure, Moderate
    38
    50
        LEU, Test of Cure, Large
    59
    81
    No statistical analyses for this end point

    Secondary: Absolute mean values of urine specific gravity at Baseline, On Therapy and Test of Cure visit

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    End point title
    		 Absolute mean values of urine specific gravity at Baseline, On Therapy and Test of Cure visit
    End point description
    Urine samples were collected from participants to assess urine specific gravity. Baseline is defined as the latest pre-dose assessment with a non-missing value. Safety population included all randomized participants who receive at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    742
    740
    Units: Ratio
    arithmetic mean (standard deviation)
        Urine Specific Gravity, Baseline
    1.0168 ( 0.00639 )
    1.0166 ( 0.00636 )
        Urine Specific Gravity, On-Therapy
    1.0175 ( 0.00663 )
    1.0166 ( 0.00636 )
        Urine Specific Gravity, Test of Cure
    1.0179 ( 0.00700 )
    1.0179 ( 0.00701 )
    No statistical analyses for this end point

    Secondary: Absolute mean values of urine potential of hydrogen (pH) at Baseline, On Therapy and Test of Cure visit

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    End point title
    		 Absolute mean values of urine potential of hydrogen (pH) at Baseline, On Therapy and Test of Cure visit
    End point description
    Urine samples were collected from participants to assess urine pH levels. Baseline is defined as the latest pre-dose assessment with a non-missing value. Safety population included all randomized participants who receive at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    733
    760
    Units: pH
    arithmetic mean (standard deviation)
        Urine pH, Baseline
    5.6 ( 0.76 )
    5.7 ( 0.79 )
        Urine pH, On-Therapy
    5.6 ( 0.68 )
    5.6 ( 0.73 )
        Urine pH, Test of Cure
    5.6 ( 0.68 )
    5.6 ( 0.70 )
    No statistical analyses for this end point

    Secondary: Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at On-Therapy and Test of Cure Visit

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    End point title
    		 Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at On-Therapy and Test of Cure Visit
    End point description
    SBP and DBP were measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value. Safety population included all randomized participants who receive at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    766
    760
    Units: Millimeters of mercury (mmHg)
    arithmetic mean (standard deviation)
        SBP, Baseline
    123.1 ( 13.23 )
    123.4 ( 12.61 )
        SBP, On-Therapy
    -0.8 ( 9.20 )
    -1.4 ( 9.64 )
        SBP, Test of Cure
    -0.9 ( 10.44 )
    -1.2 ( 10.86 )
        DBP, Baseline
    76.5 ( 8.36 )
    76.7 ( 8.25 )
        DBP, On-Therapy
    -0.2 ( 7.48 )
    -0.7 ( 7.33 )
        DBP, Test of Cure
    -0.5 ( 7.80 )
    -1.2 ( 8.28 )
    No statistical analyses for this end point

    Secondary: Change from baseline in pulse rate at On Therapy and Test of Cure Visit

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    End point title
    		 Change from baseline in pulse rate at On Therapy and Test of Cure Visit
    End point description
    Pulse rate was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value. Safety population included all randomized participants who receive at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    766
    760
    Units: beats per minute (bpm)
    arithmetic mean (standard deviation)
        Pulse rate, Baseline
    73.5 ( 9.84 )
    73.3 ( 9.91 )
        Pulse rate, On-Therapy
    1.4 ( 8.39 )
    1.7 ( 8.80 )
        Pulse rate, Test of Cure
    1.2 ( 9.63 )
    1.0 ( 10.18 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in body temperature at On Therapy and Test of Cure Visit

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    End point title
    		 Change from Baseline in body temperature at On Therapy and Test of Cure Visit
    End point description
    Temperature was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value. Safety population included all randomized participants who receive at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (on or before Day 1), On-Therapy (Days 2 to 5), and Test of cure (Days 9 to 16)
    End point values
    		 Gepotidacin Nitrofurantoin
    Number of subjects analysed
    766
    760
    Units: celsius
    arithmetic mean (standard deviation)
        Temperature, Baseline
    36.62 ( 0.372 )
    36.62 ( 0.406 )
        Temperature, On-Therapy
    -0.04 ( 0.300 )
    -0.04 ( 0.379 )
        Temperature, Test of Cure
    -0.04 ( 0.330 )
    -0.07 ( 0.400 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from the time of first dose (Day 1) through the final follow-up visit (Day 21-31).
    Adverse event reporting additional description
    Safety population included all randomized participants who receive at least 1 dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Nitrofurantoin
    Reporting group description
    		 Participants with uncomplicated urinary tract infection (acute cystitis) randomized to receive nitrofurantoin 100 mg capsule, BID, orally on Day 1 to Day 5. The total daily dose of nitrofurantoin received was 200 mg. Participants also received 2 tablets of placebo matched with gepotidacin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.

    Reporting group title
    Gepotidacin
    Reporting group description
    		 Participants with uncomplicated urinary tract infection (uUTI) (acute cystitis) randomized to receive gepotidacin 1500 milligram (mg) (2*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose of gepotidacin received was 3000 mg. Participants also received 1 capsule of placebo matched with nitrofurantoin BID, orally on Day 1 to Day 5. All doses were administered after food consumption and with water.

    Serious adverse events
    		 Nitrofurantoin Gepotidacin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 760 (0.39%)
    2 / 766 (0.26%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Sciatica
         subjects affected / exposed
    1 / 760 (0.13%)
    0 / 766 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    0 / 760 (0.00%)
    1 / 766 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    1 / 760 (0.13%)
    0 / 766 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    1 / 760 (0.13%)
    0 / 766 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Enterovesical fistula
         subjects affected / exposed
    0 / 760 (0.00%)
    1 / 766 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Dengue fever
         subjects affected / exposed
    1 / 760 (0.13%)
    0 / 766 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Food intolerance
         subjects affected / exposed
    1 / 760 (0.13%)
    0 / 766 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Nitrofurantoin Gepotidacin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    94 / 760 (12.37%)
    207 / 766 (27.02%)
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    5 / 760 (0.66%)
    8 / 766 (1.04%)
         occurrences all number
    6
    8
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    8 / 760 (1.05%)
    11 / 766 (1.44%)
         occurrences all number
    8
    11
    Headache
         subjects affected / exposed
    18 / 760 (2.37%)
    17 / 766 (2.22%)
         occurrences all number
    18
    17
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    8 / 760 (1.05%)
    20 / 766 (2.61%)
         occurrences all number
    8
    20
    Vomiting
         subjects affected / exposed
    3 / 760 (0.39%)
    10 / 766 (1.31%)
         occurrences all number
    3
    10
    Faeces soft
         subjects affected / exposed
    4 / 760 (0.53%)
    14 / 766 (1.83%)
         occurrences all number
    4
    14
    Flatulence
         subjects affected / exposed
    4 / 760 (0.53%)
    15 / 766 (1.96%)
         occurrences all number
    4
    15
    Diarrhoea
         subjects affected / exposed
    27 / 760 (3.55%)
    111 / 766 (14.49%)
         occurrences all number
    27
    116
    Nausea
         subjects affected / exposed
    29 / 760 (3.82%)
    81 / 766 (10.57%)
         occurrences all number
    29
    84
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    5 / 760 (0.66%)
    8 / 766 (1.04%)
         occurrences all number
    5
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 May 2021
    Clarifications that the primary analysis population will be “micro-ITT NTF-S (IA Set)” if the study is stopped early for success (and inclusion of corresponding outputs). Clarifications that <18 years and ≥18 to 50 years strata will be combined for use as an analysis covariate to ensure participants with valid data are not excluded.
    03 Nov 2021
    Updates to the IA recommendation framework to include a supplementary analysis performed on a supplementary analysis population defined as the primary analysis population excluding participants from investigators/sites which have had a corrective and preventative action (CAPA) put in place requiring that a supplementary analysis excluding data from these sites be performed. This population will be labeled micro-ITT NTF-S (CAPA) population and will be performed on the IA Set if applicable.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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